Expandable bioabsorbable plug apparatus and method

ABSTRACT

An apparatus for occluding a venous or arterial puncture site is disclosed including a plug insertable within, or adjacent to, a puncture site in a wall of a body lumen. An insert is forced into an aperture within the plug to cause expansion thereof. The insert may be drawn into the aperture by applying tension to a line passing therethrough and secured to the insert. Barbs may secure to the plug to engage the wall of the body lumen or adjacent tissue tract. Elongate members passing through the wall of the plug may be forced outwardly into the wall of the body lumen or adjacent tissue as the insert is forced into the aperture.

BACKGROUND OF THE INVENTION

1. The Field of the Invention

The present invention relates generally to apparatus and methods forsealing or closing passages through tissue, particularly to devices fordelivering a closure device within a passage communicating with a bodylumen, such as a blood vessel.

2. The Relevant Technology

Catheterization and interventional procedures, such as angioplasty orstenting, generally are performed by inserting a hollow needle through apatient's skin and muscle tissue into the vascular system. A guide wiremay then be passed through the needle lumen into the patient's bloodvessel accessed by the needle. The needle may be removed, and anintroducer sheath may be advanced over the guide wire into the vessel,e.g., in conjunction with or subsequent to a dilator. A catheter orother device may then be advanced through a lumen of the introducersheath and over the guide wire into a position for performing a medicalprocedure. Thus, the introducer sheath may facilitate introduction ofvarious devices into the vessel, while minimizing trauma to the vesselwall and/or minimizing blood loss during a procedure.

Upon completion of the procedure, the devices and introducer sheath maybe removed, leaving a puncture site in the vessel wall. Externalpressure may be applied to the puncture site until clotting and woundsealing occur. This procedure, however, may be time consuming andexpensive, requiring as much as an hour of a physician's or nurse'stime. It is also uncomfortable for the patient, and requires that thepatient remain immobilized in the operating room, catheter lab, orholding area. In addition, a risk of hematoma exists from bleedingbefore hemostasis occurs.

Various apparatus have been suggested for percutaneously sealing avascular puncture by occluding the puncture site. For example, U.S. Pat.Nos. 5,192,302 and 5,222,974, the use of a biodegradable plug that maybe delivered through an introducer sheath into a puncture site. Whendeployed, the plug may seal the vessel and provide hemostasis. Suchdevices, however, may be difficult to retain within the vessel, whichmay be particularly significant since it is generally undesirable toexpose the plug material within the bloodstream, where it may floatdownstream and risk causing an embolism.

Accordingly, apparatus and methods for sealing punctures or otherpassages through tissue communicating with a blood vessel would beconsidered useful.

BRIEF SUMMARY OF THE INVENTION

These and other limitations are overcome by embodiments of thedisclosure, which relates to apparatuses and methods for occluding avenous or arterial puncture site are disclosed. In particular,apparatuses and methods are disclosed for expanding a plug insertedwithin, or adjacent to, an arterial puncture site. In one embodiment, anapparatus for filling an opening in a wall of a body lumen includes aplug formed of a bioabsorbable material and defining an apertureextending through the plug from an upper surface to a lower surfacethereof, the aperture having a plug engagement surface. An insert formedof a bioabsorbable material is positioned within the aperture and has aninsert engagement surface contacting the plug engagement surface. Theplug engagement surface has an undeformed inner diameter less than anundeformed outer diameter of the insert engagement surface.

An embodiment of an apparatus for filling an opening in a wall of a bodylumen is described. The apparatus includes a plug formed of abioabsorbable material. The plug defines an aperture extending throughthe plug from an upper surface to a lower surface thereof. The aperturehas a plug engagement surface. The apparatus includes an insert formedof a bioabsorbable material positioned within the aperture. The inserthas an insert engagement surface contacting the plug engagement surface.The plug engagement surface has an undeformed inner diameter less thanan undeformed outer diameter of the insert engagement surface.

In some embodiments, elongate members may extend through the plug fromadjacent the insert and projecting outwardly from the plug. Theapparatus, in further embodiments, may include a plurality ofprojections secured to the plug proximate the lower surface andextending toward the upper surface. In still further embodiments, theplurality of projections are barbs having a wide end thereof secured tothe plug proximate the lower surface.

The plug, in some embodiments, may define a plurality of slits extendingupwardly from the lower surface a portion of a distance between theupper and lower surfaces. In further embodiments, the insert and theaperture may be tapered. The insert, in still further embodiments may bespherical.

In some embodiments, the insert may include a cylindrical portion havingat least one tapered end portion. The plug, in further embodiments, mayinclude at least one stop projecting into the aperture, the insertpositioned abutting the stop. In still further embodiments, thebioabsorbable material may be chitosan.

A further embodiment of an apparatus for filling an opening in a wall ofa body lumen is described. The apparatus includes a plug formed of abioabsorbable material. The plug defines an aperture extending throughthe plug from an upper surface to a lower surface thereof. The apparatusincludes a plurality of elongate members extending slidably through theplug and projecting into the aperture.

In some embodiments, the aperture may define a wide portion proximatethe lower surface and a narrow portion proximate the upper surface. Atapered surface, in further embodiments, may extend between the wideportion and the narrow portion. In still further embodiments, theplurality of elongate members may extend into the aperture through thetapered surface. In even further embodiments, the plurality of elongatemembers may extend toward the upper surface with distance from theaperture.

The apparatus, in some embodiments, may include a plurality ofprojections secured to the plug proximate the lower surface andextending toward the upper surface. In further embodiments, theprojections may be barbs that may be secured at a wide end thereof tothe plug proximate the lower surface. The plug, in still furtherembodiments, may define a plurality of slits extending upwardly from thelower surface a portion of a distance between the upper and lowersurfaces.

A still further embodiment of an assembly for filling an opening in awall of a body lumen is described. The apparatus includes a plug formedof a bioabsorbable material. The plug defines an aperture extendingthrough the plug from an upper surface to a lower surface thereof. Theaperture has a plug engagement surface. The apparatus includes an insertformed of a bioabsorbable material. The insert has an insert engagementsurface positionable and/or contacting the plug engagement surface. Theapparatus includes an actuating member engaging the insert andselectively movable to urge the inset engagement surface against theplug engagement surface and expand an outer diameter of the plug isexpanded.

In some embodiments, the apparatus includes a rigid catheter. Theactuating member, in further embodiments, may include a tether extendingthrough the catheter having the plug positioned between the insert andthe catheter.

An embodiment of a method for filling an opening in a wall of a bodylumen is described. The method includes inserting a plug including abioabsorbable material into the opening. The plug defines an aperture.An insert is positioned into the aperture. The insert includes abioabsorbable material. The insert has an outer diameter greater than anundeformed inner diameter of the aperture.

In some embodiments, the wall may define an inner and an outer surface.Inserting the plug into the opening, in further embodiments, may includeinserting the plug through the outer surface. In still furtherembodiments, positioning the insert in the aperture may include passingthe insert from outside the body lumen into the aperture.

Positioning the insert in the aperture, in some embodiments, may includeurging the insert into the aperture such that it abuts a stop projectinginto the aperture. In further embodiments, positioning the insert in theaperture may include drawing the insert from inside the body lumen intothe aperture. Drawing the insert from inside the body lumen into theaperture, in still further embodiments, may include tensioning a tethersecured to the insert and passing through the aperture. In yet furtherembodiments, drawing the insert from inside the body lumen into theaperture may include pressing a catheter against the upper surface ofthe plug. The tether, in even further embodiments, may extend throughthe catheter having the plug initially positioned between the insert andthe catheter.

In some embodiments, the method may include detaching the tether fromthe insert by applying an amount of tension effective to causedetachment. Positioning the insert in the aperture, in furtherembodiments, may include urging the insert against a plurality ofelongate members extending slidably through the plug and projecting intothe aperture such that the elongate members are urged outwardly from theplug into the wall of the body lumen. In still further embodiments, theplug may include a plurality of projections secured to a lower portionof the plug proximate the lower surface and extending toward the uppersurface. Inserting the plug into the opening, in yet furtherembodiments, may include inserting the lower portion of the plug intothe body lumen and drawing the lower portion outwardly from the bodylumen such that the plurality of projections are urged into the wall.

Positioning the insert in the aperture, in some embodiments, may includepositioning at least a portion of the insert in the aperture beforedrawing the lower portion proximally from the body lumen. In furtherembodiments, the plug may define a plurality of slits extending upwardlyfrom the lower surface a portion of a distance between the upper andlower surfaces. Positioning the insert in the aperture, in still furtherembodiments, may include flaring outwardly from the insert portions ofthe plug extending between adjacent slits.

Additional features and advantages of the disclosure will be set forthin the description which follows, and in part will be obvious from thedescription, or may be learned by the practice of the disclosure. Thefeatures and advantages of the disclosure may be realized and obtainedby means of the instruments and combinations particularly pointed out inthe appended claims.

BRIEF DESCRIPTION OF THE DRAWINGS

To further clarify the above and other advantages and features of thepresent invention, a more particular description of the invention willbe rendered by reference to specific embodiments thereof which areillustrated in the appended drawings. It is appreciated that thesedrawings depict only illustrated embodiments of the invention and aretherefore not to be considered limiting of its scope. The invention willbe described and explained with additional specificity and detailthrough the use of the accompanying drawings in which:

FIG. 1 is an isometric view of an assembly for occluding openings in abody lumen in accordance with an embodiment of the present invention;

FIGS. 2A through 2E illustrate a method for installing a plug within anopening in a wall of a body lumen in accordance with an embodiment ofthe present invention;

FIG. 3 illustrates a plug for occluding an opening in a wall of a bodylumen in accordance with an embodiment of the present invention;

FIG. 4 illustrates an insert for expanding a plug within an opening in awall of a body lumen in accordance with an embodiment of the presentinvention;

FIGS. 5A through 5E illustrate a method for positioning the plug of FIG.3 within an opening in a wall of a body lumen in accordance with anembodiment of the present invention;

FIGS. 6A through 6C illustrate a plug positioned within an opening in awall of a body lumen having an insert coupled to a detachment device inaccordance with an embodiment of the present invention;

FIGS. 7A and 7B illustrate alternative embodiments of a plug forinsertion within an opening in a wall of a body lumen in accordance withan embodiment of the present invention;

FIG. 8 illustrates an embodiment of an insert that may be suitable foruse with the plugs shown in FIGS. 7A-7B; and

FIGS. 9A through 9D illustrate a method for positioning the plugs ofFIGS. 7A and 7B within an opening in a wall of a body lumen inaccordance with an embodiment of the present invention.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

Referring to FIG. 1, an assembly 10 may be used to occlude punctures ina wall of a blood vessel, or other body lumen, followingcatheterization, other interventional procedures, or the like. Theassembly 10 includes a catheter 12 or like device that may be insertedthrough a procedural sheath penetrating the skin, tissue, and vesselwall in order to provide access to the body lumen. The catheter 12 canbe sufficiently rigid to permit transmission of compressive forcetherethrough. The catheter 12 may define a channel 14 for transmittingforce from a proximal end (not shown) located externally from thepatient's body to a distal end 16 thereof located within a patient'sbody during use.

The assembly 10 further includes a plug 18 located at the distal end 16of the catheter and an insert 20. The plug 18, defines a receiver 22into which the insert 20 may be inserted through the application offorce. An actuating member 24, such as a line or tether 26, transmitsforce from the proximal end of the catheter to the distal end 16 inorder to drive the insert 20 into the receiver 22. In the illustratedembodiment, the line 26 extends through the receiver 22 such that theplug 18 is captured between the insert and the distal end 16 of thecatheter. The line 26 may extend either externally along the catheter 12or through the catheter channel 14. In some embodiments, the line 26 maybe embodied as the guide wire used for locating an introducer sheath asdiscussed hereinabove.

Referring to FIG. 2A, in one method of use, the assembly 10 is used toocclude punctures 34 in a wall 36 of a body lumen 38. The puncture 34may coincide with a tissue tract 40 providing access to the puncture 34through the tissue 42, such as skin, muscle, and subcutaneous fat,covering the wall 36. As shown in FIG. 2A, a sheath 44 penetratescompletely or partially from an outer surface 46 to the body lumen 38.The plug 18 and insert 20 are introduced through the sheath 44 into thebody lumen 38 by applying pressure to the plug 18 using the catheter 12along a distal direction 48. In the illustrated embodiment, the plug 18and insert 20 exit the sheath 44 within the body lumen. However, inother methods of use, the plug 18 and insert 20 exit the sheath 44within the tissue tract 40 or puncture 34.

Referring to FIG. 2B, the plug 18 may then be drawn along the proximaldirection 50 through the puncture 34 into the position shown in FIG. 2B.In some embodiments, the plug 18 may have a thickness less than, orequal to, that of the wall 36, such that no portion of the plug 18projects into the tissue tract 40. In other embodiments, the plug 18occupies a portion of both the puncture 34 and the tissue tract 40. Instill other embodiments, the plug 18 only occupies a portion of thetissue tract 40, and no portion is located within the puncture 34.Drawing the plug 18 into the position shown in FIG. 2B may includeapplying a slight tensioning force on the line 26 to retain the insert20 proximate the plug. The slight tension can be insufficient to forcethe insert 20 into the receiver 22.

In some embodiments, the plug 18 exits the sheath 44 in the positionshown in FIG. 2B, such that it is not necessary to urge the plug 18 intothe illustrated position. The sheath 44 may be withdrawn sufficientlyprior to moving the plug 18 to the position of FIG. 2B such that theplug 18 contacts the tissue tract 40 when it is drawn into the tissuetract 40.

Referring to FIG. 2C, the insert 20 may then be drawn into the receiver22 of the plug 18. In the illustrated embodiment, the line 26 istensioned sufficiently along the proximal direction 50 to urge theinsert 20 into the receiver 22. Pressure may be applied to the catheter12 along the distal direction 48 to hinder the plug 18 from movingproximally from the puncture 34 and/or tissue tract 40. The insert 20can be sized such that forcing the insert 20 into the receiver 22 causesthe plug 18 to expand. In the illustrated embodiment, both the receiver22 and insert 20 are tapered such that both narrow with distance fromthe body lumen 38. In such embodiments, the insert 20 can be drawn intothe receiver 22 a sufficient distance such that at least a portion of anouter surface 46 of the plug 18 contacts the receiver 22 at a pointwhere the outer surface 46 has an undeformed diameter greater than thereceiver 22 at the point of contact. As shown in FIG. 2C, drawing theinsert 20 into the receiver 22 causes the plug 18 to expand and gripeither the wall 36, tissue tract 40, or both. The insert 20 can beforced into the receiver 22 to an extent sufficient to expand an outerdiameter of at least a portion of the plug 18 by between about 5 and 100percent of its original diameter. The amount of expansion of the plug 18is preferably sufficient to prevent dislocation of the plug 18 from oneor both of the tissue tract 40 and the puncture 34. The amount ofexpansion may also be chosen to reduce discomfort to the patient. Insome embodiments, the insert 20 is forced into the receiver 22 to anextent effective to expand the outer diameter of at least a portion ofthe plug by at least 2 French.

Referring to FIG. 2D, after the insert 20 is positioned within thereceiver 22, the line 26 is further tensioned in the proximal direction50 such that the line 26 detaches from the insert 20. A correspondingopposing force may be applied to the plug 18 in the distal direction 48using the catheter 12 in order to hinder movement of the plug 18 in theproximal direction 50. The tension required to detach the line 26 fromthe insert 20 can be substantially greater than that required to drawthe insert 20 into the receiver 22. For example, the tension requiredfor detachment, may be about two to ten times greater than that requiredto draw the insert 20 into the receiver 22.

Referring to FIG. 2E, the insert 20 and receiver 22 may have varioussizes and shapes. For example, the insert 20 may be substantiallyspherical and have an undeformed width 52 greater than an undeformeddiameter 54 of the receiver 22.

Referring to FIG. 3, in an alternative embodiment, a plug 60 having areceiver 62 is used to occlude punctures in a wall of a body lumen. Thereceiver 62 may be embodied as an aperture 64 extending from an uppersurface 66 to a lower surface 68 of the plug 60. For purposes of thisdisclosure, the upper surface 66 is that which is farthest from the bodylumen and the lower surface 68 is that which is closest to the bodylumen.

The aperture 64 may define a wide portion 70 and a narrow portion 72,where the wide portion is closer to the lower surface 68. A tapered, orconical, portion 74 may extend between the wide portion 70 and narrowportion 72. In some embodiments, a constriction or tapered portion 76,may be positioned between the wide portion 70 and the lower surface 68.Slits 78 may be formed in the plug 60 to facilitate expansion thereof.In the illustrated embodiment, the slits 78 extend upwardly from thelower surface 68 a portion of the distance between the upper surface 66and lower surface 68. For example, the slits 78 may extend between 20%and 80% of the distance between the upper surface 66 and lower surface68. The lengths of the slits 78 may be varied beyond the range recitedherein depending on an amount of expansion desired for the plug 60 for agiven application. The slits 78 may extend outwardly from the aperture64 completely to the outer surface 80 of the plug 60. However, in someembodiments, the slits do not completely occupy the distance from theaperture 64 to the outer surface 80 of the plug 60.

In some embodiments, projections, such as barbs 81, extend outwardlyfrom the plug 60 in order to engage the wall 36 or tissue tract 40. Inthe illustrated embodiment, the barbs 81 have a wide end 82 secured tothe plug 60 proximate the lower surface 68 and project toward the uppersurface 66. A gap 83 may be defined between distal portions of the barbs81 and the outer surface 80. In some embodiments, the barbs 81, or atleast one surface 85 of the barbs 81, may extend outwardly from theouter surface 80 with distance from the lower surface 68.

In some embodiments, elongate members 84 extend slidably through theplug 60 and include a portion 86 projecting into the aperture 64. Theplug 60 may define channels 88 sized to slidably receive the elongatemembers 84. In the illustrated embodiment, the channels 88 extend fromthe aperture 64 to the outer surface 80 of the plug 60. In theillustrated embodiment, the channels 88 extend through the taperedportion 74 of the aperture 64.

In some embodiments, the aperture 64 is centered on an axis 90 extendingbetween the upper surface 66 and lower surface 68. The channels 88 mayextend through the plug 60 at an angle 92 relative to the axis 90. Forexample, the angle 92 may be such that the channels 88 extend toward theupper surface 66 with distance from the axis 90 or aperture 64. Theangle 92 may be between 90 and 20 degrees, or between 70 and 30 degrees.In some embodiments, the channels 88 are normal to the portion of theaperture 64 through which they extend, such as the tapered portion 74.

The elongate members 84 can have a length 94 greater than a length 96 ofthe channel 88 through which they extend such that a portion 86 extendsinto the aperture 64 when one end of the elongate members 84 is flushwith the outer surface 80 of the plug 60. The end of the elongatemembers 84 closest to the outer surface 80 may be tapered, as may be theend closest to the aperture 64.

Referring to FIG. 4, an insert 100 may be used with the plug 60. Theinsert 100 may include a narrow portion 102 and wide portion 104corresponding to the narrow portion 72 and wide portion 70,respectively, of the aperture 64 defined by the plug 60. A taperedportion 106 corresponding to the tapered portion 74 may extend betweenthe narrow portion 102 and wide portion 104. The insert 100 may alsoinclude a lower tapered portion 108 corresponding to the tapered portion76 of the plug 60.

One or both of the narrow portion 102 and wide portion 104 may have anundeformed diameter greater than an undeformed diameter of the narrowportion 72 and wide portion 70 of the aperture 64, respectively, suchthat the plug 60 is expanded when the insert 100 is positioned withinthe aperture 64.

The insert 100 may further include an aperture 110 for receiving a line112 that is tensioned to draw the insert 100 into the aperture 64. Insome embodiments, the insert 110 is molded around the line 112. Aportion of the line 112 positioned within the aperture 110 may beroughened, bent, or otherwise shaped, in order to increase the amount oftension required to detach the line 112 from the insert 100.Alternatively, the coupling between the insert 100 and the line 112 maybe such that the amount of tension required to decouple the line 112from the insert 100 is greater than a tensile strength of the line 112,such that the line 112 breaks rather than detaches.

The plug 60 and insert 100 may be used in accordance with a methodillustrated in FIGS. 5A through 5E. Referring to FIG. 5A, the plug 60and insert 100 may be inserted through the sheath 44 into the body lumen38. In some embodiments, the plug 60 and insert 100 may exit the sheath44 within the puncture 34 or tissue tract 40. The plug 60 and insert 100may be urged along the distal direction 48 through the sheath 44 andoutwardly from the sheath 44 by means of the catheter 12.

The insert 100 may be oriented relative to the plug such that the plug60 is positioned between the insert 100 and the catheter 12 having theline 112 extending through aperture 64 and up the catheter lumen 14 oralong an outer surface of the catheter 12. A slight tension may beapplied to the line 112 during insertion of the plug 60 and insert 100into the lumen 38 such that the insert 100 is retained adjacent the plug60. The slight tension can be less than that required to draw the insert100 into the plug 60.

Referring to FIG. 5B, while the plug and insert 100 are positionedwithin the body lumen 38, the insert 100 may be drawn partially into theaperture 64 such that the portion of the plug 60 adjacent the lowersurface 68 is flared. The slits 78 may facilitate flaring of the plug 60during this step. In a like manner, the constriction 76 may alsofacilitate flaring of the plug 60 during this step by engaging theinsert 100. The opening defined by the constriction 76 may have adiameter greater than or equal to the narrow portion 102 of the insert100 but less than the wide portion 104. The dimensions of theconstriction 76 will therefore facilitate registration of the plug 60with the aperture 64 during insertion. The step illustrated in FIG. 5Bmay include drawing the insert 100 into the aperture 64 so that at leasta portion of the wide portion 104 is positioned within the aperture 64.In embodiments where the plug 60 exits the sheath within the puncture 34or tissue tract 40, the step illustrated in FIG. 5B may be performedwithin the puncture 34 or tissue tract 40. The sheath 44 may bewithdrawn from one or both of the puncture 34 and tissue tract 40 priorto performing the step of FIG. 5B. However, in some embodiments, thesheath 44 may remain in place.

Referring to FIG. 5C, the plug 60 may then be drawn into one or both ofthe puncture 34 and tissue tract 40. As the plug 60 is drawn into thepuncture 34 and/or tissue tract 40, the barbs 81 may be urged into thewall 36 and/or tissue 42. Drawing the plug 60 into the puncture 34and/or tissue tract 40 may include applying tension to the line 112 inthe proximal direction 50 while also drawing the catheter 12 in theproximal direction 50. In some embodiments, the step illustrated in FIG.5B may be omitted and the plug 60 may be drawn into the puncture 34and/or tract 40 without first drawing the insert 100 partially into theplug 60.

Referring to FIG. 5D, after the plug is positioned within the puncture34 and/or tissue tract 40, the insert 100 may then be drawn into theplug 60 an amount effective to expand the outer diameter of at least aportion of the plug 60. The insert 100 can be forced into the receiveraperture 64 to an extent sufficient to expand an outer diameter of atleast a portion of the plug 60 by between about 5 and 100 percent of theoriginal diameter thereof. The amount of expansion of the plug 60 ispreferably sufficient to prevent dislocation of the plug 60 from one orboth of the tissue tract 40 and the puncture 34. The amount of expansionmay also be chosen to reduce discomfort to the patient. In someembodiments, the insert 100 is forced into the aperture 64 to an extenteffective to expand the outer diameter of at least a portion of the plugby at least 2 French.

In embodiments of the plug 60 including elongate members 84 positionedwithin channels 88, the step of FIG. 5D may include drawing the insert100 into the aperture 64 an amount effective to urge a portion 114 ofthe elongate members 84 outwardly from the plug 60 and into the tissue42. In the illustrated embodiment, the insert 100 is drawn into theaperture 64 such that the tapered portion 106 abuts the tapered portion74 of the aperture 64.

Referring to FIG. 5E, after the insert 100 is drawn into the aperture64, the line 112 may be detached. The line 112 may be detached byapplying sufficient tension to the line 112 to cause it to break orseparate from the insert 100. Alternatively, a tool may be threadedthrough the catheter 12 or sheath 44 and used to cut the line 112. Theline 112 may be formed of a bioabsorbable material such that a portionof the line 112 may remain attached to the insert 100 without causingharm to a patient. Following detachment of the line 112, the catheter 12may be withdrawn.

Referring to FIGS. 6A through 6C, in alternative embodiments, the insert100 may be secured to a line 112 including anchor device 140, such asthe anchor members disclosed in U.S. application Ser. No. 12/684,400,filed Jan. 8, 2010, which is hereby incorporated herein by reference.The line 112 may include a first line portion 142 and second lineportion 144 secured to the locator device 140. When both line portions142, 144 are tensioned, a locator portion 146 remains in a widenedconfiguration having a width 148 that is substantially greater than thatof an aperture 150 extending through the insert 100. When tension isapplied to only one of the line portions 142, 144, the locator portion146 will unravel, and eventually be drawn through the aperture 150 asshown in FIGS. 6B and 6C. Accordingly, the locator device 140 may beused to draw the insert into the positions illustrated in FIGS. 5A-5E byapplying tension to both line portions 142, 144. The line 112 may thenbe detached using the locator device 140 by applying tension to only oneof the line portions 142, 144. The locator device 140 may likewise beused for the line 26 in the embodiments of FIGS. 1 through 2E.

Referring to FIG. 7A, in some embodiments a plug 160 may be configuredto receive an insert inserted in the distal direction 48. In suchembodiments, the plug 160 may define a receiver 162 for receiving theinsert embodied as an aperture 164 extending from an upper surface 166of the plug 160 toward a lower surface 168. The aperture 164 can betapered such that it narrows with distance from the upper surface 166.However, other configurations, including cylindrical apertures may alsobe used for the aperture 164.

Slits 170 may be formed in the plug 160 to facilitate expansion thereof.In the illustrated embodiment, the slits 170 extend upwardly from thelower surface 168 a portion of the distance between the upper surface166 and lower surface 168. For example, the slits 170 may extend between20% and 80% of the distance between the upper surface 166 and lowersurface 168. The lengths of the slits 170 may be varied beyond the rangerecited herein depending on an amount of expansion desired for the plug160 for a given application. The slits 170 may extend outwardly from theaperture 164 completely to the outer surface 172 of the plug 160.However, in some embodiments, the slits 170 do not completely occupy thedistance form the aperture 164 to the outer surface 172 of the plug 160.Referring to FIG. 7B, in some embodiments, one or more stops 174 mayproject into the aperture 164 a distance effective to prevent an insertfrom passing completely through the plug 160 into a body lumen 38.

Referring to FIG. 8, an insert 176 suitable for use with the plug 160may have a shape corresponding to that of the aperture 164. For example,the plug 160 may have a conical surface 178 for engagement with theaperture 164. The plug 160 may include at least a portion having anundeformed outer diameter greater than an inner diameter of at least aportion of the aperture 164.

The plug 160 and insert 176 may be used in accordance with a methodillustrated in FIGS. 9A through 9D. Referring to FIG. 9A, the plug 160and insert 176 may be inserted through the sheath 44 into the body lumen38 along the distal direction 48. In some embodiments, the plug 160 andinsert 176 may exit the sheath 44 within the puncture 34 or tissue tract40. The plug 160 and insert 176 may be urged along the distal direction48 through the sheath 44 and outwardly from the sheath 44 by means ofthe catheter 12.

The insert 176 may be oriented relative to the plug 160 such that theinsert 176 is positioned between the plug 160 and the catheter 12. Theplug 160 may be secured to one or more lines 182 extending around theinsert 176 and up the catheter lumen 14 or along an outer surface of thecatheter 12. The lines 182 may include wire, suture material, or otherstructure having sufficient tensile strength. A slight tension may beapplied to the lines 182 during insertion of the plug 160 and insert 176into the lumen 38 such that the plug 160 is retained adjacent the insert176. The slight tension can be less than that required to force theinsert 176 into the plug 160. A push rod 184 may also extend through thelumen 14 of the catheter 12 and engage the insert 176. The position ofthe push rod 184 relative to the plug 160 can be maintained sufficientlyconstant such that the insert 176 is not pushed into the aperture 164.For example, force may not be applied to the push rod in an amounteffective to urge the insert 176 into the aperture 164.

Referring to FIG. 9B, the plug 160 may then be drawn into one or both ofthe puncture 34 and tissue tract 40. The sheath 44 may also be withdrawnfrom the puncture 34 and tissue tract 40. Drawing the plug 160 into thepuncture 34 and/or tissue tract 40 may include applying tension to thelines 182 in the proximal direction 50 while also drawing the catheter12 in the proximal direction 50. In some embodiments, the plug 160 mayexit the sheath 44 within the tissue tract 40 and/or puncture 34,accordingly, drawing the plug into the position shown in FIG. 9B fromwithin the body lumen 38 is not necessary.

Referring to FIG. 9C, after the plug is positioned within the puncture34 and/or tissue tract 40, the insert 176 may be forced into theaperture 164 an amount effective to expand the outer diameter of atleast a portion of the plug 160. The insert 176 may be forced into theaperture 164 by urging the push rod 184 against the insert 176 in thedistal direction 48. In some embodiments, the insert 176 is forced intothe aperture 164 until it engages the stops 174. The insert 176 may beforced into the receiver aperture 164 to an extent sufficient to expandan outer diameter of at least a portion of the plug 160 by between about5 and 100 percent of the original diameter thereof. The amount ofexpansion of the plug 160 is preferably sufficient to preventdislocation of the plug 160 from one or both of the tissue tract 40 andthe puncture 34. The amount of expansion may also be chosen to reducediscomfort to the patient. In some embodiments, the insert 176 is forcedinto the aperture 164 to an extent effective to expand the outerdiameter of at least a portion of the plug by at least 2 French.

Referring to FIG. 9D, after the insert 176 is drawn into the aperture164, the lines 182 may be detached. The lines 182 may be detached byapplying sufficient tension to the lines 182 to cause them to break orseparate from the plug 160. Alternatively, a tool may be threadedthrough the catheter 12 or sheath 44 and used to cut the lines 182. Thelines 182 may be formed of a bioabsorbable material such that a portionof the lines 182 may remain attached to the plug 160 without causingharm to a patient. Following detachment of the lines 182, the catheter12 may be withdrawn. In yet another alternative embodiment, the lines182 may be secured to the plug 160 by means of the locator device 140illustrated in FIGS. 6A through 6C, such that the lines 182 are detachedby tensioning one of two line portions 142, 144.

The plugs 18, 60, 160 and inserts 20, 100, 176 described herein may beformed of any biocompatible, bioresorbable, bioabsorbable, andbioerodible materials, or combinations thereof. For example, and not bylimitation, suitable bioabsorbable materials may include magnesium,zinc, iron, silicon, zinc titanium, magnesium lithium, polyglycolic acid(PGA), polyhydroxybutyric acid, polyL-Lactic acid (PLLA), poly dl-lacticacid (PDLLA), polydilactidel glycolide acid, polydilactid acid, PolyDLLactide-co-glycolide, Polylactic acid, Polyhydroxyalkanoates, polylacticacid-co-caprolactone, polylactic acid-co-Chitosan, poly-phosphazenes,poly-anhydrides, degradable poly-urethanes, biodegradablepoly-carbonates, biodegradable ceramics such as those based ontricalcium phosphate or hydroxyapatite, analogous materials, co-polymersthereof, derivatives thereof, and any combinations thereof. One or bothof the plugs and inserts may also be coated with chitosan to promotehemostasis and bonding with the puncture 34 or tissue tract 40.

The present invention may be embodied in other specific forms withoutdeparting from its spirit or essential characteristics. The describedembodiments are to be considered in all respects only as illustrativeand not restrictive. The scope of the invention is, therefore, indicatedby the appended claims rather than by the foregoing description. Allchanges which come within the meaning and range of equivalency of theclaims are to be embraced within their scope.

What is claimed is:
 1. An apparatus for filling an opening in a wall ofa body lumen comprising: a plug formed of a bioabsorbable material anddefining an inner aperture extending through the plug from an uppersurface to a lower surface thereof, the inner aperture having a plugengagement surface, the plug including a plurality of channels extendingfrom an exterior surface of the plug, through a body of the plug, to theinner aperture; a plurality of elongate members each extending slidablythrough a channel of the plurality of channels of the plug andselectively projecting into the inner aperture; and an insert formed ofa bioabsorbable material configured to be slidably received within theinner aperture, the insert having a first insert engagement surfaceconfigured to contact the plug engagement surface, the plug engagementsurface having an undeformed inner diameter less than an undeformedouter diameter of the first insert engagement surface, and having asecond insert engagement surface configured to contact the plurality ofelongate members and urge the plurality of elongate members to extendoutward and away from the plurality of channels of the plug and out ofthe inner aperture.
 2. The apparatus of claim 1, wherein each elongatemember extends through the plug from adjacent the insert and projectsoutwardly from the plug.
 3. The apparatus of claim 1, further comprisinga plurality of projections secured to the plug proximate the lowersurface and extending toward the upper surface.
 4. The apparatus ofclaim 3, wherein the plurality of projections are barbs having a wideend thereof secured to the plug proximate the lower surface.
 5. Theapparatus of claim 1, wherein the plug defines a plurality of slitsextending upwardly from the lower surface a portion of a distancebetween the upper and lower surfaces.
 6. The apparatus of claim 1,wherein the insert and the aperture are tapered.
 7. The apparatus ofclaim 1, wherein the insert is spherical.
 8. The apparatus of claim 1,wherein the insert comprises a cylindrical portion having at least onetapered end portion.
 9. The apparatus of claim 1, wherein the plugfurther comprises at least one stop projecting into the aperture, theinsert positioned abutting the stop.
 10. The apparatus of claim 1,wherein the bioabsorbable material is chitosan.
 11. An apparatus forfilling an opening in a wall of a body lumen comprising: a plug formedof a bioabsorbable material and defining an inner aperture extendingthrough the plug from an upper surface to a lower surface thereof and aplurality of channels extending from an exterior surface of the plug,through a body of the plug, to the inner aperture; and a plurality ofelongate members each extending slidably through a channel of theplurality of channels of the plug, the plurality of elongate membershaving a first position selectively projecting into the inner apertureand having a second position selectively projecting out and away fromthe plug and out of the inner aperture; and an insert configured to beslidably received within the inner aperture, wherein the insert isconfigured to move the plurality of elongate members from the firstposition to the second position.
 12. The apparatus of claim 11, whereinthe aperture defines a wide portion proximate the lower surface and anarrow portion proximate the upper surface.
 13. The apparatus of claim12, further comprising a tapered surface extending between the wideportion and the narrow portion.
 14. The apparatus of claim 13, whereinthe plurality of elongate members extend into the aperture through thetapered surface.
 15. The apparatus of claim 14, wherein the plurality ofelongate members extend toward the upper surface with distance from theaperture.
 16. The apparatus of claim 11, further comprising a pluralityof projections secured to the plug proximate the lower surface andextending toward the upper surface.
 17. The apparatus of claim 16,wherein the projections are barbs secured at a wide end thereof to theplug proximate the lower surface.
 18. The apparatus of claim 11, whereinthe plug defines a plurality of slits extending upwardly from the lowersurface a portion of a distance between the upper and lower surfaces.19. An assembly for filling an opening in a wall of a body lumencomprising: a plug formed of a bioabsorbable material and defining aninner aperture extending through the plug from an upper surface to alower surface thereof and a plurality of channels extending from anexterior surface of the plug, through a body of the plug, to the inneraperture, the aperture having a plug engagement surface; a plurality ofelongate members each extending slidably through a channel of theplurality of channels of the plug and selectively projecting into theinner aperture; and an insert formed of a bioabsorbable material, theinsert having an insert engagement surface positionable contacting theplug engagement surface; and an actuating member engaging the insert andselectively movable to urge the inset engagement surface against theplug engagement surface and expand an outer diameter of the plug isexpanded.
 20. The assembly of claim 19, further comprising a rigidcatheter; wherein the actuating member is a tether extending through thecatheter having the plug positioned between the insert and the catheter.21. A method for filling an opening in a wall of a body lumencomprising: inserting a plug including a bioabsorbable material into theopening, the plug defining an inner aperture extending through the plugfrom an upper surface to a lower surface thereof, the inner aperturehaving a plug engagement surface, the plug including a plurality ofchannels extending from an exterior surface of the plug, through a bodyof the plug, to the inner aperture, a plurality of elongate members eachextending slidably through a channel of the plurality of channels of theplug and selectively projecting into the inner aperture; and positioningan insert including a bioabsorbable material into the aperture, theinsert being slidably received within the inner aperture, the inserthaving a first insert engagement surface contacting the plug engagementsurface, the plug engagement surface having an undeformed inner diameterless than an undeformed outer diameter of the first insert engagementsurface, and having a second insert engagement surface configured tocontact the plurality of elongate members and urge the plurality ofelongate members to extend outward and away from the plurality ofchannels of the plug and out of the inner aperture, the insert having anouter diameter greater than an undeformed inner diameter of theaperture.
 22. The method of claim 21, wherein the wall defines an innerand an outer surface; and wherein inserting the plug into the openingcomprises inserting the plug through the outer surface.
 23. The methodof claim 21, wherein positioning the insert in the aperture comprisespassing the insert from outside the body lumen into the aperture. 24.The method of claim 23, wherein positioning the insert in the aperturecomprises urging the insert into the aperture such that it abuts a stopprojecting into the aperture.
 25. The method of claim 21, whereinpositioning the insert in the aperture comprises drawing the insert frominside the body lumen into the aperture.
 26. The method of claim 25,wherein drawing the insert from inside the body lumen into the aperturecomprises tensioning a tether secured to the insert and passing throughthe aperture.